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    Summary
    EudraCT Number:2016-003582-25
    Sponsor's Protocol Code Number:NL59128
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003582-25
    A.3Full title of the trial
    The added effect of oral ondansetron to care-as-usual on persisting
    vomiting in children aged 6 months to 6 years, presenting at primary care
    out of hours service with acute gastro-enteritis and concomitant vomiting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The added effect of oral ondansetron to care-as-usual on persisting
    vomiting in children aged 6 months to 6 years, presenting at primary care
    out of hours service with stomach flu and concomitant vomiting
    A.3.2Name or abbreviated title of the trial where available
    COOKING
    KOOKING
    A.4.1Sponsor's protocol code numberNL59128
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointDepartment of General Practice
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1, department of General Practice
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.y.berger@umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ondansetron
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOndansetron
    D.3.2Product code RVG 31839
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastroenteritis
    Gastro-enteritis
    E.1.1.1Medical condition in easily understood language
    Stomach flu
    Buikgriep
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the added effect of oral
    ondansetron to care-as-usual (including ORT) (CAU) on persisting
    vomiting within the first 4 hours after presentation at an out-of-hours
    primary care service (OHS) in children aged 6 months to 6 years with
    acute gastroenteritis.
    E.2.2Secondary objectives of the trial
    Moreover, we intend to evaluate the predictive value of patient
    characteristics and symptoms for the risk of dehydration in a population
    of children at risk for dehydration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 6 months to 6 years;
    2. At least four reported episodes of vomiting or diarrhoea during the
    last twenty-four hours preceding presentation
    3. At least one reported episode of vomiting within the four hours
    preceding presentation;
    4. Diagnosed with AGE by a general practitioner at the OHS.
    5. Parental written informed consent.
    E.4Principal exclusion criteria
    1. Use of anti-emetics in the previous 6 hours;
    2. Known renal failure or hypoalbuminemia (as this could affect the
    assessment of hydration status);
    3. Known diabetes mellitus or inflammatory bowel disease (as this
    could increase the risk of a complicated course);
    4. A history of abdominal surgery, with suspected recurrence of original
    abdominal symptoms or strangulation ileus explaining current
    symptoms, according to the general practitioner.
    5. Known sensitivity to 5-HT3 receptor antagonists;
    6. Known prolonged QT interval;
    7. Current use of QT prolonging medication;
    8. Previous enrolment in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The number of children with persisting vomiting during the first 4 hours
    after inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    We will evaluate the primary endpoint when the study ends (estimated
    in 2018)
    E.5.2Secondary end point(s)
    Cessation of vomiting, the number of vomiting episodes during ORT,
    referral rate, the proportion that required intravenous rehydration, the
    proportion hospitalization, quality of life and healthcare use and costs
    E.5.2.1Timepoint(s) of evaluation of this end point
    We will evaluate the primary endpoint when the study ends (estimated
    in 2018)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    investigators are blinded and patients and their doctors know the given treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    oral rehydration solution
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    We will end the trial when the required sample size is reached or if
    SUSARs is reported that is severe enough to stop the study as judged
    by the DSMB
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 220
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    We want to study the effect of oral ondansetron in children aged 6
    months to 6 years. these minors are incapable of giving consent
    personally and their parents serve as their proxies.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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